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MAQUET Permanent Life Support System with Heater Unit - HSA Registration DE0009125

Access comprehensive regulatory information for MAQUET Permanent Life Support System with Heater Unit in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0009125 and owned by Maquet Cardiopulmonary GmbH. The device was registered on April 19, 2012.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS D
DE0009125
MAQUET Permanent Life Support System with Heater Unit
HSA Registration Number: DE0009125
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Product Description

MAQUET Permanent Life Support System is intended for both extracorporeal pulmonary support and cardiovascular support, or for simultaneous cardiovascular and pulmonary support. The Rataflow Centrifual Pump Systerm is intended to be used in an extracorporeal perfusion circuit to pump blood during cardiopulmonary bypass interventions and for permanent extracorporeal pulmonary or cardiovascular support. It can be used as a fully independent stand-alone unit or as part of the heart-lung machine. The Heater Unit HU 35 intended use is to maintain the patient's body temperature during permanent extracorporeal pulmonary or cardiovascular support. It is used in combination of MAQUET Rotaflow System.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0009125
Registration Date
April 19, 2012
Change Notification Approval Date
October 28, 2024
Retention Due Date
April 18, 2026
Product Owner
Short Name
Maquet Cardiopulmonary GmbH
Address
Kehler Str. 31, Rastatt 76437, GERMANY
Registrant
Address
20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Importer
Address
20 BENDEMEER ROAD, CyberHub Building, #06-02, SINGAPORE 339914 20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Model Information
Model Name(s)
Flowprobe ROTAFLOW Centrifugal Pump Flowprobe CLS 20-535 3500CP-G ROTAFLOW Drive ROTAFLOW Emergency Drive Level Sensor Pad UCP 20-981 Ultrasonic Contact ROTAFLOW Console ROTAFLOW Console medin blender for air- oxygen 1085 SPRINTER CART XL Electronic Gas Blender EGB 40 SPRINTER CART ROTAFLOW Console with ICU Kit ROTAFLOW Console with ICU Kit HU35 Heater Unit Clorina Emergency Life Support Set Quadrox-iD Pediatric Permanent Life Support Set
Model Identifier(s)
701002579 701002804 701003661 701010855 701010888 701022161 701022162 701022208 701022754 701043290 701043291 701045119 701046022 701046211 701047813 701051696 701051697 70107.2162 70107.2699 BE-ELS 3050 BE-HMOD 30000 BE-PLS 2050